Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients

Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00872352

Enrollment

Registered

2009-03-31

Start date

2009-04-30

Completion date

2009-08-31

Last updated

2009-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma, Peripheral Neuropathy

Keywords

Multiple Myeloma, Bortezomib, Peripheral Neuropathy, evaluation, evaluation of electrophysiological changes related to the dose and time of bortezomib administration, investigation of correlation between the incidence of BIPN and the subtype of myeloma

Brief summary

In the present study we are planning to study electrophysiological changes related to the dose and time of bortezomib administration in newly diagnosed patients with MM, during the first months of treatment and 6 months after ending. In addition a possible correlation between the incidence of BIPN and the subtype of myeloma and other risk factors will be investigated.

Interventions

PROCEDUREEMG

Nerve conduction study will be consisted of sequential evaluation of the motor nerves: median, ulnar, peroneal and tibial; and the sensory nerves: median, ulnar, superficial peroneal and sural nerves using a standardized protocol

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Age\> 18 * Patients with Multiple Myeloma stage II, III (Durie and Salmon staging) prior to Bortezomib Therapy * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Be willing and able to comply with the protocol treatment for the duration of the study * Patient's written informed consent

Exclusion criteria

* Multiple Myeloma on progression * Incidence of Relapsed or Refractory Myeloma * Patients with the existing neuropathy at the time of the diagnosis

Design outcomes

Primary

Measure	Time frame
A dose-related neurotoxic effect of bortezomib will be determined through regression analysis with the change in TNSr as the dependent variable Bortezomib doses will use as independent variables.	3 months

Secondary

Measure	Time frame
To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy	4 months

Countries

Israel

Contacts

Primary ContactHusam Ghoti, MD

drghoti123@yahoo.com972-35028778

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026